Oversee all sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex Medical, as well as purchased products labeled and sold by Teleflex Medical. Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products, including custom and made-to-order kits, for impact of sterilization.Division InformationThe Corporate division is the central operating unit of the company setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. Company headquarters are located just outside of Philadelphia in Wayne, PA.
•Prepare and assist in managing sterilization validations/annual revalidations, test protocols/reports for all internal and external Teleflex Medical sterilization facilities.
•Work with the Sterility Assurance Project Manager to lead teams associated with the annual revalidation activities.
•Address issues arising from sterilization non-conformances.
•Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market.
•Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods. Evaluate the effectiveness of existing sterilization methods on custom or made-to-order kits.
•Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives.
•Maintain and assist in managing the sterilization and biocompatibility program/policy for Teleflex Medical to endure all products and processes comply with the regulatory standards.
•Create strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
•Create strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products.
•Provide sterilization expertise during audits of internal and external sterilization suppliers according to a documented audit plan.
•Provide oversight and ensure company-wide, consistent and compliant methods for the following: EO Residuals, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing. (These are considered "microbiological methods".)
•Train appropriate company personnel on sterilization and microbiological methods and processes as needed.
•Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
•Perform miscellaneous projects and duties at the direction of Quality Assurance and Manufacturing Management.
•Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
EDUCATION / EXPERIENCE REQUIREMENTS:
•B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background
•Minimum of 8 years of experience in sterilization of medical devices
SPECIALIZED SKILLS & OTHER REQUIREMENTS: Additional preferred or required qualifications.
•Expertise and extensive knowledge in EO and gamma radiation sterilization
•Regulatory, cGMP, QSR knowledge base
•Statistical knowledge (DOE, SPC, Sample comparison, etc.)
•Supplier audit skills
•Computer literate (MiniTab, Word, Excel, etc.)
•Strong communication skills (written and verbal)
•Ability to communicate and operate effectively with multiple teams
•Negotiation and strong problem solving skills
•Ability to manage multiple tasks in order to meet/exceed deadlines
Proven ability to adapt to shifting priorities, work with minimal supervision, to resolve problems/conflicts, and demonstrate sound reasoning ability.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.